Systems and methods for treating tissue with radiofrequency energy

• US 10,386,990 B2
• Filed: 09/17/2016
• Issued: 08/20/2019
• Est. Priority Date: 09/22/2009
• Status: Active Grant

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Mederi Rf, LLC
• Inventors: Shikhman, Oleg, Rutan, William W., Stemple, Danny L., Smith, Penny R., Thompson, Gregory K., McGilvary, Thomas L.
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Vahdat, Khadijeh A
• Application Number:
  US15/268,574
• Publication Number:
  US 20170049500A1
• Time in Patent Office: 1,067 Days
• Field of Search: 606 33- 41
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/044 : the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1807 : using light other than laser radiation
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2034/252 : indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 : being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 2218/002 : Irrigation
• CPC Class Codes: A61B 2218/007 : Aspiration
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 90/361 : Image-producing devices, e.g. surgical cameras
• CPC Class Codes: G06F 3/04817 : using icons graphical or visual programming using iconic symbols G06F8/34
• CPC Class Codes: G16H 20/30 : relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to heat tissue to create lesions without ablating the tissue. The system includes a first treatment device having at least one electrode for applying radiofrequency energy to tissue, a controller including a connector to which a first treatment device is coupled for use, and a generator for applying radiofrequency energy to the electrodes. The controller controls application of energy so that the tissue is thermally treated to create lesions but preventing thermal treatment beyond a threshold which would ablate the tissue.

Claims

1. A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to heat tissue to create lesions at a treatment range defined between under heating tissue to fail to achieve a therapeutic affect and overheating tissue to cause tissue ablation, the system comprising a controller including a connector to which a first treatment device having a plurality of electrodes for applying radiofrequency energy to tissue is coupled for use, and a generator for applying radiofrequency energy to the electrodes, the improvement comprising a multiple error checking system which if an error is detected which indicates disabling of an electrode of the plurality of electrodes of the treatment device, the system is configured to check for a repeat of the error and configured to determine if disabling is warranted or energy application is warranted to thereby reduce the likelihood of undertreatment of tissue, and further having temperature sensors associated with the plurality of electrodes and an automatic pump system configured to increase the flow of cooling fluid if measured temperature exceeds a predetermined value to maintain tissue temperature below a tissue ablation threshold.

2. The system of claim 1, wherein the multiple error checking system is configured to repeat the error check three times.

3. The system of claim 1, wherein the first treatment device includes a plurality of temperature sensors, the temperature sensors are configured to measure temperature when the electrodes are deployed at the lesion level but prior to application of RF energy to indicate to a user if electrode position needs to be adjusted.

4. The system of claim 1, wherein the system is configured to detect improper energy flow through a cable and through the electrodes.

5. The system of claim 1, wherein the system is configured to intermittently check impedance throughout a surgical procedure utilizing the first treatment device.

6. The system of claim 1, wherein if an error is detected the system is configured to suspend energy flow but does not permanently interrupt energy flow until the error is rechecked.

7. A system for controlling operation of a radiofrequency treatment device to apply radiofrequency energy to tissue to heat tissue to create lesions at a treatment range defined between under heating tissue to fail to achieve a therapeutic effect and overheating tissue to cause ablation of tissue, the system comprising a controller including a connector to which a first treatment device having a plurality of electrodes for applying radiofrequency energy to tissue is coupled for use, and a generator for applying radiofrequency energy to the electrodes, the controller configured to control application of energy so that the tissue is thermally treated to create lesions but prevent thermal treatment beyond a threshold which would ablate the tissue, the system further including a cut off function to cut off energy flow to disable an electrode of the plurality of electrodes if one of multiple potential errors is detected, the system further containing a feature to prevent premature disabling of an electrode of the plurality of electrodes, and further including an automatic pump system to increase the flow of cooling fluid if measured temperature exceeds a predetermined value.

8. The system of claim 7, wherein the feature to prevent premature disabling of the electrode comprises a multiple error check in which if an error is detected, a measurement is rechecked to determine if the error is still present before cut off of the energy flow.

9. The system of claim 7, further comprising an operation system configured to execute on a display screen a first graphical interface guiding use of the first treatment device coupled to the controller, the controller configured to visually prompt a user in a step-wise fashion to perform a process using the coupled treatment device of forming a pattern of lesions in a body region in a plurality of axially spaced lesion levels, each lesion level including a plurality of circumferential spaced lesions.

10. The system of claim 7, wherein the first treatment device includes a three dimensional basket and an expandable balloon within the basket to expand the basket, the basket including a plurality of spines and the plurality of electrodes are movable within the plurality of spines.

11. The system of claim 7, wherein the electrodes have penetrating tips to penetrate tissue.

12. The system of claim 7, wherein if the measured temperature reaches a second predetermined value, the pump system is configured to automatically move to its maximum pump speed and cannot be overridden by a user.

13. The system of claim 12, wherein if a third higher value is reached, the electrode is disabled, and further comprising an indicator to indicate if the electrode is disabled.

14. The system of claim 7, wherein the first treatment device includes a handle and a shielded printed circuit board contained in the handle, the printed circuit board enabling precise measurement of tissue and electrode parameters to regulate tissue temperature to prevent thermal treatment of tissue beyond a tissue ablation threshold, and the shield configured to reduce interference to minimize unwanted disabling of electrodes.

15. The system of claim 14, wherein the printed circuit is asymmetrically mounted within the handle.

16. The system of claim 14, wherein the printed circuit board includes a coded identification for the first treatment device.

17. The system of claim 7, wherein a coded identification for the first treatment device is positioned in the handle and a printed circuit board for temperature calculation is positioned outside the handle.

18. The system of claim 7, wherein if an error is detected the system is configured to suspend energy flow but does not permanently interrupt energy flow until the error is rechecked.

19. The system of claim 7, further comprising temperature sensors associated with the plurality of electrodes.